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NCT00848900 Clinical Trial

Guangzhou Outdoor Activity Longitudinal Study

Myopia Clinical Trial

Official title:
A Controlled Clinical Trial of the Effect of Increases Time Outdoors in the Prevention of Juvenile-onset Myopia in Chinese Children

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT00848900
Other study ID # GOAL2009
Secondary ID
Status Enrolling by invitation
Phase N/A
First received February 19, 2009
Last updated November 19, 2010
Start date April 2009
Est. completion date July 2012

Study information
Verified date October 2010
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess whether outdoor activities are effective in preventing the development and progression of juvenile-onset myopia in Chinese children.

Description:

1. To determine if increased engagement in outdoor activities reduces the development and progression of myopia in Chinese school children.

2. To identify the risk factors associated with the development and progression of juvenile-onset myopia.

3. To characterize the interaction between refractive error and education.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 2000
Est. completion date July 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All the students in Grade 1

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Outdoor activity
Adding 1 hour outdoor time into school curricula

Locations
Country Name City State
China Zhongshan Ophthalmic Center Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cycloplegic refraction 1 year No
Secondary Visual acuity 6 months No
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